The Effectiveness of Biofeedback for Individuals With Long-term Post-concussive Symptoms

NCT03338036 | Completed Results FDA Device

• 1 other identifier: Western University REB 109760
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Most concussions resolve within 7-10 days, but approximately 40% of individuals do not fully recover and suffer from persistent post-concussive symptoms. This 8-week intervention study will evaluate the efficacy of heart rate variability (HRV) biofeedback and neurofeedback on reducing the number and severity of concussion symptoms.

Conditions

Post-Concussion Syndrome

Keywords

Concussion; Post-Concussion Syndrome; Biofeedback; Heart Rate Variability; Neurofeedback

Outcome Measures

Primary Outcomes (3)

• Change In SDNN

  The interval between heartbeats, specifically the artifact-free intervals between R waves in the QRS complex, will be measured. This is known as the standard deviation of the norm (SDNN), and is a universal method of quantifying HRV (Camm et al., 1996). This information is collected using the Mindja application for android devices, created by Evoke Neuroscience.The physiologically relevant norms are a mean of 50 (SD 16) and a range from 32-93 ms (Shaffer F, Ginsberg JP. An Overview of Heart Rate variability Metrics and Norms. Frontiers in Public Health. 2017 Sep;5(258):1.)

  baseline and post-intervention (8 weeks)

• Number of Participants Making Driving Simulator Mistakes

  Participants will perform a driving simulation task using the DriveSafety CDS-250 driving simulator. It will record the performance, and afterwards a trained rater will review and evaluate the number of driving errors using a standardized assessment form. The number of individuals that made a driving simulator mistake are reported. The minimum is zero and the maximum is the number of participants in the Arm/Group. We are not aware of any physiologically relevant ranges for this measure.

  baseline and post-intervention (8 weeks)

• Change In Electrocardiograph Amplitudes

  The amplitude and power of alpha, beta, theta, and delta frequencies will be evaluated relative to reference norms (Gevensleben et al., 2010) and expressed as Z-scores (deviation from the mean divided by the standard deviation). In terms of physiologically relevant norms, 99% of the population will have scores between -3 and +3. This information is collected and stored in a secured cloud between Evoke Neuroscience and Western University.

  baseline and post-intervention (8 weeks)

Secondary Outcomes (2)

• Change In Number and Severity of Post-concussive Symptoms

  baseline and post-intervention (8 weeks)

• Change In Anxiety

  baseline and post-intervention (8 weeks)

Study Arms (3)

Heart Rate Variability/Neurofeedback

EXPERIMENTAL

Participants in this arm of the study will receive HRV biofeedback and neurofeedback. HRV biofeedback will occur twice daily, using an android device and application. Additionally, three times per week they will have one-hour long neurofeedback sessions.

Device: Heart Rate Variability Biofeedback; Device: Neurofeedback

Post-Concussed Control Group

NO INTERVENTION

Age-matched, previously concussed individuals that have completed the same concussion rehabilitation program (Brain Ex 90) will be recruited for this arm.

Non-Concussed Control Group

NO INTERVENTION

Age-matched individuals who have not been diagnosed with a concussion in the previous two years

Interventions

Heart Rate Variability Biofeedback DEVICE

HRV biofeedback constitutes initial training with the android device and application, and HRV training performed at home. This training will occur twice daily, and each session will take five minutes.

Heart Rate Variability/Neurofeedback

Neurofeedback DEVICE

LORETA Z-Score neurofeedback training will occur three times per week with a trained study investigator.

Heart Rate Variability/Neurofeedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants in HRV and the HRV/Neurofeedback intervention arms, and the post-concussion control arm:
• Previously suffered a clinically diagnosed concussion
• Participated in, completed, and have been discharged from the BrainEx90 outpatient concussion rehabilitation program at Parkwood Institute
• Continued post-concussive symptoms
• years of age or older
• Access to transportation
• Capable of utilizing hand-held technology (ie. cell phone, tablet, etc.)
• Holds a valid Driver's License
• English speaking
• Participants in the non-concussed control arm:
• years of age or older
• Holds a valid driver's license
• English speaking
• Has not suffered a concussion in the last two years

You may not qualify if:

• All participants:
• Any heart disease, pacemaker, abnormal heartbeat patterns, coronary artery disease, or bypass surgery
• Any mental health disorder that would interfere with participation in the study
• Under 18 years of age
• Unable to provide written informed consent or complete questionnaires due to language or cognitive difficulties
• Inability to operate a motor vehicle
• Inability to look at a digital screen for 30 minutes
• Participants in the non-concussed control arm:
• \. Suffered a concussion in the last two years

Sponsors & Collaborators

• Western University, Canada: lead
• Parkwood Hospital, London, Ontario: collaborator

Study Sites (1)

University of Western Ontario

London, Ontario, N6A3K7, Canada

Location

Related Publications (13)

• Bivona U, D'Ippolito M, Giustini M, Vignally P, Longo E, Taggi F, Formisano R. Return to driving after severe traumatic brain injury: increased risk of traffic accidents and personal responsibility. J Head Trauma Rehabil. 2012 May-Jun;27(3):210-5. doi: 10.1097/HTR.0b013e31822178a9.

  PMID: 21829135 BACKGROUND

• Conder RL, Conder AA. Heart rate variability interventions for concussion and rehabilitation. Front Psychol. 2014 Aug 13;5:890. doi: 10.3389/fpsyg.2014.00890. eCollection 2014.

  PMID: 25165461 BACKGROUND

• Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.

  PMID: 8598068 BACKGROUND

• Fisk GD, Schneider JJ, Novack TA. Driving following traumatic brain injury: prevalence, exposure, advice and evaluations. Brain Inj. 1998 Aug;12(8):683-95. doi: 10.1080/026990598122241.

  PMID: 9724839 BACKGROUND

• Gevensleben H, Holl B, Albrecht B, Schlamp D, Kratz O, Studer P, Rothenberger A, Moll GH, Heinrich H. Neurofeedback training in children with ADHD: 6-month follow-up of a randomised controlled trial. Eur Child Adolesc Psychiatry. 2010 Sep;19(9):715-24. doi: 10.1007/s00787-010-0109-5. Epub 2010 May 25.

  PMID: 20499120 BACKGROUND

• Ingebrigtsen T, Waterloo K, Marup-Jensen S, Attner E, Romner B. Quantification of post-concussion symptoms 3 months after minor head injury in 100 consecutive patients. J Neurol. 1998 Sep;245(9):609-12. doi: 10.1007/s004150050254.

  PMID: 9758300 BACKGROUND

• Lagos, L., Bottiglieri, T., Vaschillo, B., & Vaschillo, E. (2012). Heart Rate Variability Biofeedback for Postconcussion Syndrome: Implications for Treatment. Biofeedback, 40(4), 150-153. doi:10.5298/1081-5937-40.4.05

  BACKGROUND

• Lagos, L., Thompson, J., & Vaschillo, E. (2013). A Preliminary Study: Heart Rate Variability Biofeedback for Treatment of Postconcussion Syndrome. Biofeedback, 41(3), 136-143. doi:10.5298/1081-5937-41.3.02

  BACKGROUND

• Lehrer PM, Gevirtz R. Heart rate variability biofeedback: how and why does it work? Front Psychol. 2014 Jul 21;5:756. doi: 10.3389/fpsyg.2014.00756. eCollection 2014.

  PMID: 25101026 BACKGROUND

• Milleville-Pennel I, Pothier J, Hoc JM, Mathe JF. Consequences of cognitive impairments following traumatic brain injury: Pilot study on visual exploration while driving. Brain Inj. 2010;24(4):678-91. doi: 10.3109/02699051003692159.

  PMID: 20235770 BACKGROUND

• Munivenkatappa A, Rajeswaran J, Indira Devi B, Bennet N, Upadhyay N. EEG Neurofeedback therapy: Can it attenuate brain changes in TBI? NeuroRehabilitation. 2014;35(3):481-4. doi: 10.3233/NRE-141140.

  PMID: 25238859 BACKGROUND

• Preece MH, Horswill MS, Geffen GM. Driving after concussion: the acute effect of mild traumatic brain injury on drivers' hazard perception. Neuropsychology. 2010 Jul;24(4):493-503. doi: 10.1037/a0018903.

  PMID: 20604623 BACKGROUND

• Thompson, M., Thompson, L., Reid-Chung, A., & Thompson, J. (2013). Managing Traumatic Brain Injury: Appropriate Assessment and a Rationale for Using Neurofeedback and Biofeedback to Enhance Recovery in Postconcussion Syndrome. Biofeedback, 41(4), 158-173. doi:10.5298/1081-5937-41.4.07

  BACKGROUND

MeSH Terms

Conditions

Post-Concussion Syndrome; Brain Concussion

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Head Injuries, Closed; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Wounds, Nonpenetrating; Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Results Point of Contact

• Title: Dr Jim Dickey, Associate Professor
• Organization: University of Western Ontario

[email protected]

519-661-2111

Study Officials

• James P Dickey, PhD

  Western University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor-Investigator

Model Details: This study will include two intervention arms and two control arms. The intervention arms will include 1) heart rate variability biofeedback, 2) a combination of heart rate variability biofeedback and neurofeedback. The control arms will be 1) age-matched post-concussive individuals and 2) age-matched individuals who have not been diagnosed with a concussion in the last two years.

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: November 9, 2017
• Study Start: January 1, 2018
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: August 9, 2022
• Results First Posted: June 4, 2020

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)